National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Advancing HIV Prevention through
Transformative Behavioral and Social Science Research (R01)

This Funding Opportunity Announcement (FOA) encourages
applications that will advance generalizable knowledge about HIV prevention
through transformative behavioral and social science research. An underlying
assumption for this funding opportunity is that methods of and findings from
social and behavioral studies can make essential contributions to research
that utilizes biomedical modalities. In addition, biomedical perspectives
are essential for the advancement of social and behavioral HIV research on
HIV prevention. Therefore, this FOA invites studies that are comprehensive in
the sense that the reciprocal influences of relevant variables, whether
social, behavioral, or biomedical are included in study design and
interpretation. This FOA is intended to address the goals of the National HIV
AIDS Strategy, and therefore studies should address issues that are highly
relevant to the domestic (i.e., United States) HIV problem.

Key Dates

Posted Date

June 21, 2011

Open Date (Earliest Submission Date)

December 6, 2011

Letter of Intent Due Date

December 6, 2011

Application Due Date(s)

January 6, 2012 by 5:00 PM local
time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

June 1, 2012

Expiration Date

January 7, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

In July of 2010, the US National HIV/AIDS Strategy was
released. The Strategy presents a vision of the United States as a place where
new HIV infections rarely occur and where all persons have access to needed
care. As one response to the Strategy, the NIH Office of AIDS Research (OAR)
sponsored and convened the “Social and Behavioral HIV Prevention Research Think
Tank” in September of 2010. This meeting brought together experts from
research and academic institutions, government agencies, and community
constituency groups to exchange information on the state of HIV social and
behavioral prevention research in the U.S., to develop ideas for further
research, and to describe opportunities for partnerships and collaborations. Prior
to the meeting, workgroups met and deliberated several themes and identifying key
research questions. These deliberations formed the foundation for discussions at
the meeting as well as the proposed research recommendations generated at the
September OAR meeting.

The high priority research invited through this FOA reflects
recommendations from both the OAR Think Tank and the priorities of the trans-NIH
Plan for HIV-Related Research (http://www.oar.nih.gov/strategicplan/),
with emphasis on their overlapping priority areas as well as gap areas in the
NIH social and behavioral prevention research portfolio that holds promise for
contributing to the goals of the National AIDS Strategy.

Objectives
of This Research Strategy

The objective of this research initiative is to expand the
knowledge base for the development or implementation of interventions in a
transformative way that has the potential to impact the prevention of HIV
transmission or acquisition and result in decreases in HIV incidence within the
United States at the population level.

Areas of research interest include, but are not limited to, the
following:

I.
Complex Models in HIV Prevention

The use of combination approaches to HIV prevention
consisting of several interventions implemented at the individual, network and
community level is essential for addressing HIV prevention needs. The efficacy
of many individual prevention components has been established, and research on
their efficacy and effectiveness continues. Although research has begun to
address the impact of combinations of interventions, there is a need to
elucidate trans-disciplinary principles that will guide the development and implementation of complex prevention
interventions. The multiple pathways by which interventions can have an
impact, the interaction of social and individual variables, and the intersection
of viral and host factors all must be considered in developing prevention
programs. Research is needed to assist in integrating information about
components of prevention packages and their interactions in order to guide
decisions about primary and secondary prevention programming.

Research to evaluate HIV transmission models which utilize
quantitative and qualitative methods, (e.g., ethnographic, experimental,
modeling, and longitudinal studies), to better understand the dynamics of
relationships, behaviors, and context, and link biological and social variables
with intervention and program outcomes and cost-effectiveness analyses.

Research to promote development and application of methodological
diversity (including mixed-method studies and multi-factorial designs) for
analyses of multi-level, multi-behavior, multi-temporal, and multi-stage
approaches to HIV prevention, in order to develop quantitative estimates of the
likely and/or maximal impact that addressing a specific variable or set of
variables could have on HIV risk behavior and HIV transmission.

II.
Social Processes and Social Change

Relatively few evidence-based interventions directed at the
social-structural level exist. Research is needed to address complex causal
pathways influencing both proximal and distal HIV-associated outcomes at the
individual, group, and population levels. Such research can be informed by
combined research perspectives, such as molecular biology approaches to track
viral spread in conjunction with changes in transmission risk dynamics.
Specific examples include, but are not limited to:

Investigations of processes, such as mobility, migration,
stigmatization, community resilience, and marginalization as units of analysis
to determine their association with risk and to develop strategies to intervene
in these processes.

The impact on HIV prevention efforts as a result of structural
and institutional changes, such as health care reform, changes in marriage
laws, increased availability of substance abuse treatment, and the
implementation of the National HIV/AIDS Strategy which targets expanded
testing, access to antiretrovirals and improved linkage and engagement with
care.

Research utilizing natural experiments, comparative studies, and
cohort analyses in order to better define social constructs such as
vulnerability, marginalizing conditions, stigma and resilience, and determine
their role in HIV prevention efforts.

Studies using research and design methodologies from a variety of
disciplines, such as economics and political science, to better evaluate the
relationships among HIV risk and structural and environmental factors,
incorporating methods examining the natural course of behavior change.

In 2010, the results of three landmark studies on HIV
prevention were announced. The CAPRISA 004 trial (Science. 2010 Sep
3;329(5996):1168-74) found that use of a microbicide gel containing 1%
tenofovir was effective in reducing a woman’s risk of becoming HIV infected
during sex by 39% and reducing her risk of becoming infected with Herpes
Simplex Virus 2 (HSV2) by 51%, when combined with risk reduction counseling,
condoms, and treatments for sexually transmitted infections (STIs). Further,
the research showed greater efficacy of the gel among those who were most
consistent in using it. Women who used the gel in more than 80% of their sex
acts had a 54% reduction in HIV infections whereas those who used the gel in
less than half of their sex acts had a 28% reduction in HIV infection. The
iPREX study (R Grant et al. 2010. NEJMoa1011205), investigated a pre-exposure
prophylaxis, or PrEP, regimen. Results showed about 44% fewer HIV infections
occurred among men who have sex with men (MSM) and transgendered individuals
who were receiving an oral combination of emtricitabine and tenofovir along
with a comprehensive package of HIV prevention services as compared with a
similar group receiving a placebo with the comprehensive HIV prevention package.
As in the CAPRISA 004 trial, understanding adherence to study drug proved
critical to interpreting the results. PrEP was more protective for those
regularly taking the medication, whether measured by pill counts, bottle
counts, self-reports, or blood drug level assays and different measurement
techniques revealed different estimates of adherence.

In May 2011, interim results from the HIV Prevention
Trials Network (HPTN) 052 study demonstrated that HIV-infected men and
women who took oral antiretrovirals while their immune systems were still
relatively healthy dramatically reduced sexual transmission of HIV to their
uninfected partners (http://www.niaid.nih.gov/news/newsreleases/2011/Pages/HPTN052.aspx).
This randomized clinical trial compared two groups of HIV discordant couples: in
one group the HIV- infected partners received immediate treatment with a
combination of three antiretrovirals while in the other group the HIV-infected
partners began antiretrovirals when their CD4 counts fell below 250 cells/mm³
or an AIDS-related event occurred. Both groups received the same amount of care
and counseling, including counseling on safe sex practices, free condoms,
treatment for STIs, regular HIV testing, and frequent evaluation and treatment
for any complications related to HIV. Of the 28 linked infections, which were
confirmed by genetic analysis of viruses from both partners, 27 infections
occurred among the 877 couples in which the HIV-infected partner did not begin
antiretrovirals immediately. Only one case of HIV infection occurred among
those couples where the HIV-infected partner immediately initiated therapy.
This finding was statistically significant and suggests that earlier initiation
of therapy led to a 96 percent reduction in HIV transmission to the
HIV-uninfected partner.

These studies add to the list of effective biomedically-based
interventions to prevent transmission, such as the use of antiretrovirals to
prevent mother-to-child HIV transmission, circumcision to prevent HIV
acquisition by heterosexual males, drug abuse treatment, HIV testing, and
post-exposure prophylaxis. For reasons that are yet unclear but perhaps
related to behavioral and social issues, the FEM-Prep trial of pre-exposure
prophylaxis for HIV prevention among heterosexual women was not able to
demonstrate efficacy (http://www.fhi.org/en/AboutFHI/Media/Releases/FEM-PrEP_statement041811.htm).
Understanding and integrating behavioral and social context factors are critical
to achieving the maximal effect of biomedical interventions. Examples of
additional research needed include, but are not limited to:

Investigations of the social and behavioral factors that are
likely to influence the implementation, acceptance, and use of biomedical
interventions, utilizing different levels of analysis such as individuals,
dyads, networks, communities, organizations, and social policies.

Studies to better understand and address existing and potential
disparities in access to prevention and care services in order to improve the
health of racial and ethnic populations highly affected by HIV in the United
States.

Research on ethical issues in the conduct of scientifically
rigorous prevention studies, such as informed consent, partial efficacy, the
implications of trial participation, potential adverse impact, public security,
and the inclusion of difficult-to-recruit and most at risk populations.

Translational research to optimize and scale-up interventions
shown to be efficacious in reducing HIV incidence, through clarifying the
processes of identifying, adapting, disseminating and sustaining
interventions, as well as methods to ensure quality control in implementation.
Studies should address methodologies for designing, conducting, and analyzing
such research and for securing relevant community participation in the design,
conduct, and interpretation of research.

Studies that utilize available data from ongoing programs to
better understand principles of program management and effectiveness that can
be generalized to other contexts and that allow evaluation of impact and
cost-effectiveness.

Population-effectiveness studies where randomization is above the
unit of the individual and studies using non- randomized controlled trials that
have sufficient rigor to allow inferences about the effects of prevention
programs.

IV.
New Technologies for Information Management and Communication

Advances in communication technology now pervade daily life
and social relationships. Social media are viewed as normative means of
communication and interaction. Such media can be associated with risky sexual
activity as well as substance abuse, but may also assist individuals in risk
behavior change. Interventions to effectively reduce HIV risk using this
technology are critical. Specific examples include, but are not limited to:

Research to evaluate the use and cost-effectiveness of
information and communication technologies for HIV prevention.

Studies of the evolving information technology environment and
its influences, using measures of individual, small group, community, and
societal level variables, to determine potential means of intervention to
reduce risk.

Studies to develop and investigate the utility of accessible
forums and repositories of technology experience, protocols, and applications
to advance research on HIV prevention or application of HIV prevention research
results.

Studies of the use of technology, such as medical records
management, appointment reminders, and text messages, to improve implementation
of prevention or prevention-related care (such as substance abuse treatment or
early involvement in HIV care) and enhance adherence.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The participating ICs intend to commit $5,000,000 in FY
2012 to fund 10 to 12 grants in response to this FOA.

Award Budget

Budgets for direct costs of up to $500,000 per year may be
requested. This limit is exclusive of any consortium F&A costs.

Award Project Period

The total project period may not exceed 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms,
and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan..

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

In order to expedite review, applicants are requested to
notify the NIMH Referral Office by email at nimhreferral@mail.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria (as
applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Are the studies proposed likely to
advance a research agenda of a broad integrative approach to HIV prevention?
Will these studies guide the development and implementation of complex
prevention interventions? Does the research proposed address the complex causal
pathways that influence both proximal and distal HIV associated outcomes at
multiple levels? Are these studies likely to increase understanding of the
complexities of effective integration of behavioral and social context in to
biomedical interventions? When appropriate, is state-of-the-art communication
technology utilized in a creative and integrative way?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project? Have the investigators demonstrated a keen understanding of the multifarious aspects of integrating
strong behavioral science into biomedical interventions? Do the investigators
articulate a reasonable plan to address this?

Innovation

Does the application challenge and seek to shift current
research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? Does the proposed research build on the underlying assumption that methods of and findings from
social and behavioral studies can make essential contributions to research
utilizing biomedical modalities? Does the research capitalize on the
multidisciplinarity both within and across the broad spectrum of sciences
involved in HIV/AIDS to approach prevention in innovative ways?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Do the overall strategy, methodology, and analyses build on previous findings and thus have the
potential to significantly improve efforts to prevent HIV transmission or
acquisition and result in decreases in HIV incidence at the population level?

Environment

Will the scientific environment in which the work will
be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? Is the environment proposed reasonable to provide the necessary
infrastructure to meet the goals of the proposed study?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Does the proposed research expand the knowledge base for the
development or implementation of interventions in a transformative way that has
the potential to decrease HIV incidence within the United States at the
population level?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by CSR , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the appropriate National Advisory Council of the participating ICs. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Transformative nature of proposed research.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.